Background: Responsibilities will include the timely development of regulatory submission strategies, registration dossiers and management of departmental projects, in cooperation with product development, project management and other relevant divisions globally. Further tasks will be to establish and maintain relationships with Notified Bodies and other approving bodies, to ensure fast and smooth product approval, identify and communicate potential risks in submissions, maintain international product licences, provide support as required during audits, and participate in training.
Suitable candidates would typically be degree qualified in a relevant discipline such as the natural sciences or engineering, with at least 2 years experience as a Regulatory Affairs Professional in the Medical Devices sector and an understanding of ISO 13485:2003 and/or ISO 9001. Fluent in spoken and written English is a must, as are excellent communication and interpersonal skills in general. Any additional language an advantage.
This is an important position, and maximum effort is being directed at providing flexibility in work hours.
For more information on this vacancy, or any other Medical Device Regulatory opportunities, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at a.boroky@nonstop-devices.com